{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "San Clemente",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85053",
      "recalling_firm": "ICU Medical, Inc.",
      "address_1": "951 Calle Amanecer",
      "address_2": "N/A",
      "postal_code": "92673-6212",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US:AK,AL,AR,AZ,CA,CO,CT,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,SD,TN,TX,UT,VA,WA,WI,WY    OUS: Canada    *** \"REF\" numbers AH7117 and B30211 were not marketed or distributed within the US***",
      "recall_number": "Z-1912-2020",
      "product_description": "REF: B30211, 37\" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211",
      "product_quantity": "1000 units",
      "reason_for_recall": "There is a potential that   IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber.  An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery).  This could result in under-delivery of critical medication which may lead to serious adverse health consequences.",
      "recall_initiation_date": "20191004",
      "center_classification_date": "20200506",
      "termination_date": "20211228",
      "report_date": "20200513",
      "code_info": "Lot # 4168832 *Product not distributed within the US",
      "more_code_info": ""
    }
  ]
}